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Friends, Family & Food: Food Allergy App for Youth ( F3A-App ) (F3A-App)

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ClinicalTrials.gov Identifier: NCT05093114
Recruitment Status : Completed
First Posted : October 26, 2021
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:
Objective: This Phase II STTR grant incorporated user feedback collected in an earlier development project to build interactive, web-based software that helps children with food allergies learn about their condition and gain self-management skills. This highly interactive game allows children to progress through virtual scenes to help them learn about food avoidance, symptom detection, and reaction management. In addition, this project built gaming complexity, with more levels and game options, of the two interactive games "Label Learning: Like it or Lose it!" and "Reaction Action!".

Condition or disease
Food Allergy in Children

Detailed Description:

The central goal of this project was to develop an interactive, game-based application (App) for school-aged children (aged 8-12) with food allergies (FA) that would increase knowledge, improve behavioral skills for disease management, and ultimately reduce risk of negative outcomes. An effective FA intervention for children should target content areas of food avoidance and reaction management, and across these areas facilitate knowledge acquisition, develop behavioral skills, and provide practice using these skills in social contexts. Our Friends, Family, and Food App (F3A-App), consists of four related parts: (a) an interactive, game-based application that is the core of the program, (b) the experiential scenarios in interactive environments (e.g., school cafeteria vignette) that target knowledge and behavioral skills practice in social contexts, (c) two engaging multi-level games to build skills in food avoidance (Label Learning: Like it or Lose it!) and symptom assessment (Reaction Action!), and (d) a multi-tiered reward system that uses token economy-based reinforcement to enhance motivation and engagement (SeaLife Spectacular). From a user perspective, the interactive, game-based application provides opportunities to practice behavioral skills (e.g. negotiating pressures to accept trigger foods, requesting assistance from adults, responding to teasing/bullying) in role-play situations with immediate feedback and reinforcement.

In this Phase II project, we proposed to produce a fully-developed version of the F3A-App, including added content and enhanced features, and evaluate the final product in a randomized clinical trial.

The specific aims of Phase II were:

  1. To refine the F3A-App based on the user feedback and data collected in Phase I.
  2. To develop and field test additional content, including two additional interactive environments (family gathering, school pot-luck); and to increase gaming complexity (i.e. more levels and options) in Label Learning: Like it or Lose it! and Reaction Action! We conducted a small open trial in which 40 children with FA, ages 8-12, used selected segments containing the newly developed content. Children used the application for 2 weeks on their home computer or tablet. Feedback about device preference and usage was used to determine our focus in the Evaluation Stage (Aim 3).
  3. To assess the efficacy of the F3A-App vs. Standard Care (brief office visit and educational handouts) in a randomized clinical trial with 100 children with FA, ages 8-12. We expected the F3A-App would improve children's FA knowledge and self-efficacy to manage FA (primary outcomes) and would increase parent-child communication regarding FA management relative to Standard Care (secondary outcome). Our crossover design also enabled us to evaluate combined effects of Standard Care and the F3A-App through typical treatment channels (e.g., is the greatest efficacy found after a physician refers family to use the App after an office visit?) This Phase II STTR targeted pediatric FA, a critical public health problem of increasing prevalence. Our approach was innovative by incorporating an emphasis on behavioral skills practice using a platform that is engaging, interactive, affordable, and has high potential for broad dissemination. We envision that the F3A-App will ultimately serve as a template for interactive, game-based applications for children with other chronic conditions requiring self-management, such as asthma, diabetes, and celiac disease.

This record describes only the Open Trial portion of this Phase II STTR project.

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies
Actual Study Start Date : May 18, 2015
Actual Primary Completion Date : February 2, 2016
Actual Study Completion Date : February 2, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Feedback interviews [ Time Frame: Session 2, about 5 weeks after Session 1 and post-intervention ]
    A semi-structured interview assessing child participants' opinions and feedback regarding game segments.


Secondary Outcome Measures :
  1. Food Allergy Knowledge Questionnaire [ Time Frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline) ]
    Child report

  2. Food Allergy Management Efficacy [ Time Frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline) ]
    Child report

  3. Food Allergy Independent Measure [ Time Frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline) ]
    Parent/Caregiver report

  4. Food Allergy Caregiver-Child Communication [ Time Frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline) ]
    Parent/Caregiver report



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Children with food allergy to one of the four most common FAs that may cause anaphylaxis (peanut, tree nut, milk, and egg)
Criteria

Inclusion Criteria:

  • child must be 8 -12 years of age
  • child must have an active diagnosis of food allergy (FA), specifically one or more of the four most common FAs that may cause anaphylaxis (peanut, tree nut, milk, and egg), confirmed by a physician within the past two years
  • child and parent must speak and read English
  • child must have access to a computer with internet access
  • child must have access to a smartphone or tablet

Exclusion Criteria:

  • Any chronic health condition requiring substantial dietary self-management (e.g., diabetes).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05093114


Sponsors and Collaborators
Rhode Island Hospital
Investigators
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Study Chair: Kathy Mann-Koepke, PhD Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT05093114    
Other Study ID Numbers: R42 HD075524 (Open Trial)
First Posted: October 26, 2021    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rhode Island Hospital:
Food Allergy
Intervention
Virtual
Pediatric
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate